摘要
目的探讨及评估尿微量蛋白检测项目在临床检测及应用中存在的风险。方法应用前瞻性风险分析(PRA)方法评估尿微量蛋白各检测项目[微量白蛋白(m Alb)、IgG、转铁蛋白(Trf)、α_1-微球蛋白(α_1-MG)和β_2-微球蛋白(β_2-MG)]在分析前、分析中和分析后3个阶段存在的风险。尿微量蛋白检测过程中出现的主要错误包括患者准备不当、识别错误、标本处理不当、延迟分析、分析不当、报告不当和结果误读。风险评分综合考虑风险发生的可能性(P)、风险结果(C)的严重程度以及风险被发现的概率(简称D)3个方面。P和C的评分均为0~10分,D的评分为1~3分,风险总评分(简称R)=P×C。综合R和D的评分将风险分为3类:可接受的风险、不可接受的风险和待改善的风险。然后用鱼骨图分析导致不可接受的风险和待改善的风险的所有因素,并选出最主要的因素。结果尿微量蛋白检测项目没有不可接受的风险,待改善的风险有2项,分别为"β_2-MG延迟分析"和"分析不当"。鱼骨图分析显示影响"β_2-MG延迟分析"的原因是夜间不检测和周末不检测,导致"分析不当"的主要原因是没有室内质控和未参加室间质评。结论 PRA能有效地识别风险。对于识别出的不可接受的风险和待改善的风险,分析其主要的影响因素,便可有针对性地采取措施,实施风险控制。
Objective To investigate and evaluate the risk of urine micro-protein determinations in clinical test and application. Methods The risk of urine micro-protein determinations,including the determinations of microv albumin(mAlb),IgG,transferrin(Trf),alpha1-microglobulin(α1-MG) and beta2-microglobulin(β2-MG),in pre-analytical process,intra-analytical process and post-analytical process was evaluated by prospective risk analysis(PRA). The main failures in urine micro-protein determinations included inappropriate preparation of patients,identification errors,inappropriate sample handling,delayed analysis,inappropriate analysis,inappropriate reporting and misunderstanding of results. The risk analysis concerned the probability(P) of failure occurring,the consequence(C) of failure and the chance of determining(D). P and C scored on a scale of 0-10,and D scored on a scale of 1-3. The overall risk score(R) is calculated according to R=P×C. The risk was classi?ed by the scores of R and D into acceptable,unacceptable and suboptimal levels. Then,a ?shbone diagram outlined the cause and effect of unacceptable or suboptimal risk. Main causes were selected by discussion. Results No unacceptable risk was identified in urine micro-protein determinations. There were 2 items of suboptimal risk,which were inappropriate analysis and delayed analysis of β2-MG. Fishbone diagram illustrated the main cause ofinappropriate analysis was lacking of quality control. No determination at night and weekend was the main cause for the delayed analysis of β2-MG. Conclusions PRA can identify risk effectively. It should take measures for mitigating or preventing risks by analyzing the main causes of unacceptable and suboptimal risks.
出处
《检验医学》
CAS
2017年第11期962-965,共4页
Laboratory Medicine
关键词
微量蛋白
尿液
前瞻性风险分析
鱼骨图
Micro-protein
Urine
Prospective risk analysis
Fishbone diagram